BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TEMPUS CERVICAL PLATE SYSTEM

    MDR report key: 6537194 · Received May 2, 2017

    Report

    Report Number
    3008853203-2017-00003
    Event Type
    Malfunction
    Date Received
    May 2, 2017
    Date of Event
    March 29, 2017
    Report Date
    May 1, 2017
    Manufacturer
    NEUROSTRUCTURES, INC
    Product Code
    KWQ
    UDI-DI
    00841508100218
    PMA / PMN Number
    K131374
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    NO PARTS WERE RETURNED FOR EVALUATION.

    Description of Event or Problem · 1

    REVISION OF CASE DONE ON (B)(6) 2016 DUE TO BROKEN PLATE LOCKING MECHANISM AND SCREW BACK OUT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    320629 TEMPUS CERVICAL PLATE SYSTEM TEMPUS KWQ NEUROSTRUCTURES, INC UNKNOWN 00841508100218

    Patients

    Seq Age Sex Outcome Treatment
    1